BS EN 16602-70-57:2015 BSI Standards Publication Space product assurance — Dry Heat Bioburden Reduction for Flight Hardware BS EN 16602-70-57:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 16602-70-57:2015 The UK participation in its preparation was entrusted to Technical Committee ACE/68, Space systems and operations A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 86648 ICS 49.140 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2015 Amendments/corrigenda issued since publication Date Text affected BS EN 16602-70-57:2015 EN 16602-70-57 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM September 2015 ICS 49.140 English version Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware Assurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de vol Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für Flughardware This European Standard was approved by CEN on 16 November 2014 CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members Ref No EN 16602-70-57:2015 E BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Table of contents European foreword Introduction Scope Normative references Terms and abbreviated terms 3.1 Terms from other standards 3.2 Terms specific to the present standard .8 3.3 Abbreviated terms 10 3.4 Nomenclature 10 Principles 11 Requirements 13 5.1 General requirements .13 5.2 Product requirements .13 5.3 5.4 5.2.1 Product compatibility with process 13 5.2.2 Product cleanliness 13 5.2.3 Product packaging 14 5.2.4 Product release 14 Process requirements .14 5.3.1 Procedure requirements 14 5.3.2 Bioburden reduction cycle requirements 17 Equipment requirements 17 Annex A (normative) Dry heat bioburden reduction specification - DRD 19 Annex B (normative) Dry heat bioburden reduction proposal - DRD 21 Annex C (normative) Dry heat bioburden reduction report - DRD 23 Annex D (informative) D-values for to orders of magnitude reduction 25 Annex E (informative) Effective D-values for to orders of magnitude reduction 27 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Bibliography 29 Figures Figure 4-1: Dry heat bioburden reduction process overview 12 Figure D-1 : D-values for to orders of magnitude reduction 25 Figure E-1 : Effective D-values for to orders of magnitude surface reduction 27 Tables Table D-1 : D-values for to orders of magnitude reduction 26 Table E-1 : Effective D-values for to orders of magnitude surface reduction 28 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) European foreword This document (EN 16602-70-57:2015) has been prepared by Technical Committee CEN/CLC/TC “Space”, the secretariat of which is held by DIN This standard (EN 16602-70-57:2015) originates from ECSS-Q-ST-70-57C This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association This document has been developed to cover specifically space systems and has therefore precedence over any EN covering the same scope but with a wider domain of applicability (e.g : aerospace) According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space Article IX of the Outer Space Treaty constitutes the primary statement of international law: “States parties shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, when necessary, adopt appropriate measures for this purpose.” Harmful contamination in that sense is defined as biological contamination, including organic-constituents, to protect the environment in order to allow future exobiology research The Committee On Space Research (COSPAR) has established some planetary protection guidelines, based on the Outer Space Treaty These guidelines impose requirements on spaceflight missions according to target body/mission type combinations The objective of this Standard is to ensure that proper procedures for reducing the microbiological contamination on flight hardware are in place to meet the planetary protection constraints BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Scope This standard defines procedures for the reduction of microbiological contamination of flight hardware using heat The procedures described in this standard cover: • Reduction of microbiological contamination on exposed surfaces, mated surfaces and encapsulated in materials • Reduction of microbiological contamination in dry, ambient and uncontrolled humidity environments This standard also sets requirements for the conditioning of the flight hardware, bioburden reduction cycle development, and equipment to be used for applying a bioburden reduction procedure This standard may be tailored for the specific characteristics and constraints of a space project in conformance with ECSS-S-ST-00 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standard For dated references, subsequent amendments to, or revision of any of these publications not apply However, parties to agreements based on this ECSS Standard are encouraged to investigate the possibility of applying the more recent editions of the normative documents indicated below For undated references, the latest edition of the publication referred to applies EN reference Reference in text Title EN 16601-00-01 ECSS-S-ST-00-01 ECSS system - Glossary of terms EN 16601-40 ECSS-M-ST-40 Space project management - Configuration and information management EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformances control system EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control EN 16602-70-53 ECSS-Q-ST-70-53 Space product assurance - Materials and hardware compatibility tests for sterilization processes EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance - Microbial examination of flight hardware and cleanrooms EN 16602-70-58 ECSS-Q-ST-70-58 Space product assurance - Bioburden control of cleanrooms IEST-STD-CC1246D Institute of environmental science and technology product cleanliness levels and contamination control program BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Terms and abbreviated terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40, ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and in particular the following: Bioburden Bioburden reduction Cleanliness level Product item 3.2 Terms specific to the present standard 3.2.1 ambient humidity absolute humidity of no more than 12 g/m3 NOTE 3.2.2 This is equivalent to 70 % relative humidity at 20 °C and 1000 hPa pressure cycle sequence of individual steps NOTE 3.2.3 For the purpose of this standard, the individual steps are preconditioning, heat-up, bioburden reduction as defined by the selected procedure, cool-down Each steps has associated control and monitoring parameters like time and temperature D-value time required to achieve inactivation of 90 % of a population of the test microorganisms under stated conditions BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) 18 f Instrumentation used to monitor the process parameters shall be calibrated g Details of calibration shall be recorded h Instrumentation used to monitor the process parameters shall be only used within the valid range and time period of the calibration i Any nonconformance shall be recorded in an NCR in compliance with requirements from the clause 5.1 of the ECSS-Q-ST-10-09 j NCR shall be processed in conformance with requirements from ECSS-QST-10-09 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Annex A (normative) Dry heat bioburden reduction specification - DRD A.1 DRD identification A.1.1 Requirement identification and source document This DRD is called from ECSS-Q-ST-70-57, requirement 5.1b A.1.2 Purpose and objective The purpose of the specification is to request a service to reduce the bioburden of a product This specification describes the product, constraints to be met during the processing of the product and the bioburden levels that need to be achieved at the end of the bioburden reduction process The specification is written by the customer A.2 Expected response A.2.1 a Scope and content The dry heat bioburden reduction specification shall include: Objective of the bioburden reduction Identification and description of the product that has to undergo a bioburden reduction, including thermal model Expected start and end bioburden levels Identification of selected bioburden reduction procedure in conformance with requirements from the clause 5.3.1 and the temperature to be used Identification of any pre-conditioning necessary for the product Identification of any particular or molecular contamination control necessary before, during and after the bioburden reduction process is applied 19 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Identification of any bioburden recontamination control necessary for the product before, during and after the bioburden reduction process is applied, including packaging Target(s) on the product for which a bioburden reduction is intended NOTE Locations to measure the temperature on the product 10 Expected release of volatiles from the product during the bioburden reduction process application 11 Specification of the packaging materials and related procedures NOTE 20 Pay attention to ESD issues 12 Deliverables 13 Quality standards A.2.2 None Targets on the product can be on exposed surfaces, mated surfaces or encapsulated in materials Special remarks BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Annex B (normative) Dry heat bioburden reduction proposal DRD B.1 DRD identification B.1.1 Requirement identification and source document This DRD is called from ECSS-Q-ST-70-57, requirement 5.1c B.1.2 Purpose and objective The purpose of the proposal is to describe a bioburden reduction process for a product It is written by a supplier of a bioburden reduction service and is the response to a bioburden reduction specification B.2 Expected response B.2.1 a Scope and content The proposal for dry heat bioburden reduction shall include: Bioburden reduction procedure planned to be used List and description of equipment needed for applying and controlling the bioburden reduction process Description of the thermal boundary conditions of the equipment for the selected bioburden reduction temperature Product specific cycle development Pre-conditioning for the product Particular and molecular contamination control before, during and after the bioburden reduction process is applied Bioburden recontamination control for the product before, during and after the bioburden reduction process is applied The dry heat bioburden reduction cycle, including heat-up time, bioburden reduction temperature and time as defined by the 21 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) procedure used (see 5.3.1), cool-down time, and temperature set points for the control of the cycle NOTE To achieve this requirement it can be necessary to perform some tests with a thermal representative model equipped with thermocouples under the same conditions as planned for the flight hardware bioburden reduction NOTE Two kinds of temperature measurements are typically used in a dry heat bioburden reduction – one kind to monitor the temperature of the product and another kind to monitor and control the process In case a representative model is used for the cycle development, the temperature measurement on the product can be done during cycle development Locations to measure the temperature on the product to establish the dry heat bioburden reduction cycle NOTE 10 The loading pattern of the equipment 11 Loading pattern specific locations to measure process parameters to control the cycle NOTE 12 Proper monitoring and documentation is necessary to allow parametric release of the product, see 5.2.4 13 The level of purity of the air or other gases used in the process 14 Environmental conditions and control of the equipment NOTE This includes e.g., any level of particulate or molecular contamination control, filtrations systems, use of forced air flow with direction and velocity, use of pumps, pressure level 15 Deliverables 16 Quality standards B.2.2 22 Typical process parameters to control the cycle are temperature and humidity Values for process parameters and their tolerances to control the bioburden reduction cycle NOTE None This is usually done based on thermal analysis of the product Special remarks BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Annex C (normative) Dry heat bioburden reduction report - DRD C.1 DRD identification C.1.1 Requirement identification and source document This DRD is called from ECSS-Q-ST-70-57, requirements 5.1e C.1.2 Purpose and objective The purpose of the report is to document the bioburden reduction of a product It is written by the supplier of a bioburden reduction service C.2 Expected response C.2.1 a Scope and content The dry heat bioburden reduction report shall include: Description of the product Bioburden procedure and temperature used Description of bioburden reduction cycle, including records of raw and processed monitoring and control parameters of the cycle actually used on the product, heat-up time, bioburden reduction temperature and time as defined by the procedure used in conformance with requirements from the clause 5.3.1, cool-down time, and temperature set points for the control of the cycle Start and end bioburden levels The loading pattern of the equipment Loading pattern specific locations to measure process parameters to control the cycle Values for process parameters and their tolerances to control the bioburden reduction cycle The measured level of purity of the air or other gases used in the process 23 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Description of equipment used 10 Description of the Installation qualification of the equipment to be used for bioburden reduction 11 Record of the environmental conditions and control of the including any level of particulate or molecular contamination control, filtrations systems, use of forced air flow with direction and velocity, use of pumps, pressure level 12 Status of Operational qualification of the equipment 13 Calibration/maintenance records for all the equipment used 14 Particular or molecular contamination control used before, during and after the bioburden reduction process 15 Bioburden recontamination control used before, during and after the bioburden reduction process 16 Documented installation qualification 17 Documented operational qualification 18 Documented maintenance records 19 Documented performance qualification 20 Description of nonconformance or deviations 21 Applied quality standards 22 Description and resolution of nonconformances C.2.2 None 24 Special remarks BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Annex D (informative) D-values for to orders of magnitude reduction Figure D-1 and Table D-1 are graphical and tabular representations of equations [5-1], [5-2], and [5-3] Figure D-1: D-values for to orders of magnitude reduction 25 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Table D-1: D-values for to orders of magnitude reduction Temperature dry surface ambient surface dry mated ambient mated uncontrolled humidity (surface, mated) and encapsulated T (°C) Dvalue (min) Dvalue (min) Dvalue (min) Dvalue (min) Dvalue (min) 110 155,4 268,7 310,8 537,5 1533,8 111 139,2 236,5 278,5 473,0 1392,5 112 124,8 208,1 249,6 416,2 1247,9 113 111,8 183,1 223,7 366,2 1118,3 114 100,2 161,1 200,4 322,2 1002,1 115 89,8 141,8 179,6 283,5 898,1 116 80,5 124,7 161,0 249,5 804,8 117 72,1 109,8 144,2 219,5 721,2 118 64,6 96,6 129,3 193,2 646,3 119 57,9 85,0 115,8 170,0 579,2 120 51,9 74,8 103,8 149,6 519,1 121 46,5 65,8 93,0 131,6 465,2 122 41,7 57,9 83,4 115,8 416,8 123 37,4 50,9 74,7 101,9 373,6 124 33,5 44,8 67,0 89,7 334,8 125 30,0 39,4 60,0 78,9 300,0 130 17,3 20,8 34,7 41,6 173,4 135 10,0 11,0 20,0 22,0 100,2 140 5,8 5,8 11,6 11,6 57,9 145 3,6 3,6 7,1 7,1 35,7 150 2,3 3,6 4,5 4,5 22,7 160 1,0 1,0 2,0 2,0 10,0 170 0,5 0,5 1,0 1,0 4,88 180 0,26 0,26 0,5 0,5 2,57 190 0,14 0,14 0,3 0,3 1,45 200 0,09 0,09 0,2 0,2 0,86 26 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Annex E (informative) Effective D-values for to orders of magnitude reduction Figure E-1 and Table E-1 and are graphical and tabular representations of equations [5-4] and [5-5] Figure E-1: Effective D-values for to orders of magnitude surface reduction 27 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Table E-1: Effective D-values for to orders of magnitude surface reduction 28 Temperature T (°C) Effective Dvalue (hours) 110 56,4 111 54,6 112 52,9 113 51,2 114 49,6 115 48,1 116 46,6 117 45,2 118 43,8 119 42,5 120 41,2 121 40,0 122 38,8 123 37,6 124 36,5 125 35,4 130 30,6 135 17,1 140 9,7 145 5,6 150 3,2 160 1,1 170 0,42 180 0,16 190 0,065 200 0,027 BS EN 16602-70-57:2015 EN 16602-70-57:2015 (E) Bibliography EN reference Reference in text Title EN 16601-00 ECSS-S-ST-00 ECSS system - Description, implementation and general requirements ESSB-ST-U-001 Issue ESA planetary protection requirements ISO 11138:2006 Sterilization of health care products - Biological indicator systems ISO 20857:2010 Sterilization of health care products - Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices 29 This page deliberately left blank This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all sectors choose standards to help them achieve their goals Information on standards We can provide you with the knowledge that your organization needs to succeed Find out more about British Standards by visiting our website at bsigroup.com/standards or contacting our Customer Services team or Knowledge Centre Buying standards You can buy and download PDF versions of BSI publications, including British and adopted European and international standards, through our website at bsigroup.com/shop, where hard copies can also be purchased If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our Customer Services team Subscriptions Our range of subscription services are designed to make using standards easier for you For further information on our subscription products go to bsigroup.com/subscriptions With British Standards Online (BSOL) you’ll have instant access to over 55,000 British and adopted European and international standards from your desktop It’s available 24/7 and is refreshed daily so you’ll always be up to date You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by becoming a BSI Subscribing Member PLUS is an updating service exclusive to BSI Subscribing Members You will automatically receive the latest hard copy of your standards when they’re revised or replaced To find out more about becoming a BSI Subscribing Member and the benefits of membership, please visit bsigroup.com/shop With a Multi-User Network Licence (MUNL) you are able to host standards publications on your intranet Licences can cover as few or as many users as you wish With updates supplied as soon as they’re available, you can be sure your documentation is current For further information, email bsmusales@bsigroup.com BSI Group Headquarters 389 Chiswick High Road London W4 4AL UK We continually improve the quality of our products and services to benefit your business If you find an inaccuracy or ambiguity within a British Standard or other BSI publication please inform the Knowledge Centre Copyright All the data, software and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that owns copyright in the information used (such as the international standardization bodies) and has formally licensed such information to BSI for commercial publication and use Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior written permission from BSI Details and advice can be obtained from the Copyright & Licensing Department Useful Contacts: Customer Services Tel: +44 845 086 9001 Email (orders): orders@bsigroup.com Email (enquiries): cservices@bsigroup.com Subscriptions Tel: +44 845 086 9001 Email: subscriptions@bsigroup.com Knowledge Centre Tel: +44 20 8996 7004 Email: knowledgecentre@bsigroup.com Copyright & Licensing Tel: +44 20 8996 7070 Email: copyright@bsigroup.com